This highly interactive workshop gives participants hands-on experience in applying practical techniques and solutions to solve computerized systems compliance challenges. Participants will discuss and analyze case studies, apply newly acquired knowledge to hypothetical case-study systems, and have the opportunity to discuss their own real-life challenges with other participants and an expert trainer. Participants should come prepared to work in groups to devise workable and creative solutions to realistic problems and case study scenarios, facilitated by the instructor.

This course was developed by members of the ISPE GAMP® Community of Practice. GAMP® was established by industry leaders to interpret and improve the understanding of regulations governing the use of computerized systems in pharmaceutical manufacturing.

Includes Webinar

This course includes a pre-recorded Webinar that provides a review of the basics prior to the classroom course. Access information will be provided via email one week prior to the start of the training event.

At the conclusion of this Webinar, participants will be able to:

Understand why the industry developed the GAMP® guidance, the objectives of the Guidance, the history of the GAMP® initiative and how it has evolved

Review the structure and content of GAMP® 5

Define key GAMP® 5 themes, concepts, and the GAMP system Life Cycle

Course Modules

Introduction and Overview

Industry Trends and Updates

Key Concepts

Lifecycle Activities

Regulated Company Activities & Supplier Assessment

Quality Risk Management

End User Applications

Applying GAMP® 5 to Legacy Systems

Take Back to Your Job

Build upon and expand understanding of the regulatory requirements and expectations for the compliance of computerized systems used in pharmaceutical manufacturing

Apply this understanding to example systems and case studies

Analyze case studies and apply the GAMP® 5 process for achieving compliance and fitness for intended use

Apply quality risk management and risk assessment concepts

Attendance Suggested For

Quality assurance and quality control specialists, validation specialists, manufacturing supervisors, technical support personnel, engineers, MIS professionals and all levels of management who need a practical understanding of computerized system compliance

Computer system vendors or consultants, engineering contractors, and validation service companies

Those who have previously attended a GAMP® Basic Principles training course or those whose practical experience has provided the equivalent level of knowledge